Rapid Alert System

SAHPRA collaborates with the World Health Organisation (WHO) and other regulatory authorities in sharing and receiving alerts on falsified and substandard medicines in other countries via the rapid alert emails to SAHPRA/WHO Substandard and Falsified Medicines (SF) Focal Person.

 

Should SAHPRA detect medicines that are substandard or falsified in the market, rapid communication will be facilitated to prevent the use of such medicines which would be harmful to consumers. SAHPRA SF Focal Person will share the information to the WHO through the Global Surveillance Monitoring System (GSMS) and the information would be disseminated to other countries.

Reporting concerns or problems relating to quality of products can be received from the inspectors, public complaints, manufacturers or relevant stakeholders. The information can be reported verbally or in writing. Once information is received regarding availability of poor-quality medicines, this will be registered under the Health products quality investigations.  If the medicines are not registered, SAHPRA regulatory compliance inspectors will conduct inspection/s and remove the unregistered medicines from the market. Registered medicines found to be of poor quality, SAHPRA communicates with the manufacturers through the local agents to confirm if the medicines were manufactured by the facilities as indicated in the product labels. If the manufacturers agree to have manufactured the medicines, a recall of the medicines and other actions appropriate for recalls is enforced.

 

Should the manufacturers confirm that the medicines were not manufactured by the facilities despite the resemblance, the medicines are classified as falsified. A sample of such medicines are sent to the SAHPRA designated laboratory for identification test and assay to get information and assess the actual health risk of the medicines and guidance on proper decision making.

 

SAHPRA where necessary, will communicate or issue press/media release to alert and warn the public against the use of such products.

Rapid Alert Notification of a Quality Defect

Case 17 Coryx Throat Spray Rapid Alert

Case 18 Demetrin Tablets Rapid Alert

Case 19 Adco-Napacod Rapid Alert

Case 20 Rocephin 1G vials Rapid Alert